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Vivalytic SARS-CoV-2 DT, Flu A/B, RSV
Table 8c – Clinical Sensitivity (PPA) and Specificity (NPA) for Flu A
and RSV oropharyngeal swab samples in eNAT® (95 % confidence
interval, prospective clinical study)
Flu A
PPA 93.3 % (86.05– 97.51 %)*
NPA 100.0 % (97.60 – 100.00 %)
RSV A/B
PPA 97.0 % (92.23 – 99.18 %)**
NPA 100.0 % (96.64 – 100.00 %)
Clinical performance data of Vivalytic SARS-CoV-2 DT, Flu A/B, RSV in comparison to the
Allplex™ RV Master Assay (Seegene). Prospective clinical study with in total 242 valid
results tested for Flu A and RSV each, gained from 125 patient samples tested with two
different catridge lots and generated at one study site.
* 6 samples were tested as false negative.
** 4 samples were reported as false negativ.
Table 9 – Document History
Revision 01
Revision 02
Revision 03
Revision 04
Initial document
Update of Performance data
Precision of result matrix, addition of further
performance data, Correction of header of Table 1
Added missing paragraph of intended use in German
version
– Annex
149
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